Redpin Therapeutics, Inc.

Kriya Therapeutics is diving into the nonalcoholic steatohepatitis space with newly acquired Tramontane Therapeutics. While it’s been a rocky year for many, everything is smooth sailing at Kriya Therapeutics—one of biotech’s top money raisers last year—as it continues its acquisition streak. This time, Kriya has snapped up Tramontane Therapeutics and will be developing a nonalcoholic steatohepatitis (NASH) program sourced from the gene therapy biotech. Kriya now wholly owns the Autonomous University of Barcelona (Universitat Autònoma de Barcelona, or UAB) spinout and its neurodegenerative- and metabolic-disease-focused portfolio of fibroblast growth factor 21 (FGF21) assets. Financial details of the deal were not disclosed. Tramontane’s lead program is an adeno-associated virus-vector-powered therapy made to express a consistent level of the native FGF21 protein, which can have beneficial metabolic effects across several organs and is a biological target in NASH, a severe form of nonalcoholic fatty liver disease. NASH can progress to fibrosis, also known as liver scarring, and potentially lead to irreversible damage known as cirrhosis or even liver failure.   "We are very impressed with the data associated with the Tramontane FGF21 program, which has consistently established strong efficacy and durability across multiple validated animal models of obesity and NASH," Kriya co-founder and CEO Shankar Ramaswamy, M.D., said about the one-time intramuscular gene therapy. "The addition of Tramontane’s FGF21 program strategically aligns with our metabolic disease portfolio which also includes a one-time gene therapy candidate for insulin-dependent diabetes."  Kriya touts a pipeline of gene therapies for ophthalmology, neurology and metabolic disease, but this marks the company’s first dive into the crowded NASH space. Currently, there aren’t any approved treatments available for stopping or reversing the condition, with Vantage estimating that the market could grow to $108.4 billion worldwide by 2030. Kriya’s portfolio, meanwhile, is bolstered by the more than $600 million raised to date. Last year, the biotech scored the fifth largest private biotech fundraise of 2022, raking in a $270 million series C in May of that year. That round was boosted by a further $150 million extension this past July, bringing the round's total to $430 million.    The company’s strategy is to build a gene therapy provider, starting with the manufacturing footprint. Just three months after closing its series A in May 2020, the company secured an operational manufacturing facility in North Carolina. Since then, Kriya has bought up smaller gene therapy companies and penned new licensing pacts to bulk up its early-stage pipeline. In November, the biotech bought out Redpin Therapeutics for an undisclosed amount. The acquisition added neurology treatments to Kriya’s pipeline, namely for epilepsy and trigeminal neuralgia.

Kriya Therapeutics hopes to be in or near the clinic in one year. Gene therapy biotech Kriya Therapeutics is continuing its acquisition streak to build out a pipeline, this time with a focus on the brain. The North Carolina-based biotech is buying Redpin Therapeutics to expand, acquiring treatments for epilepsy and trigeminal neuralgia. There were no dollar figures included in Wednesday’s deal announcement and a press contact for Kriya said financial details weren’t being disclosed.  Redpin uses chemogenetics—the engineering of protein receptors to interact with small molecules—to selectively turn on or off disease-causing neurons. In other words, it’s a process that flips conventional drug development upside down. Instead of designing the small molecule that interacts with existing receptors, the company is designing the receptors to interact with an existing small molecule.  The ion channel receptors that Redpin has designed only respond in the presence of FDA-approved smoking cessation med varenicline. The company has said that it’s built around varenicline because it’s useful at small doses and has suitable brain penetration. News about the company’s progress has been sparse since a $15.5 million series A, backed in part by Takeda, closed in March 2020.  For Kriya, this is the latest in a string of smaller business deals meant to build out the company’s gene therapy business. Earlier this year, Kriya acquired Warden Bio, an AAV-focused gene therapy developer working on treatments for glycogen storage disorders. That acquisition was intended to be the foundation of Kriya’s rare disease unit. A couple of months later, Kriya inked an agreement with Twist Bioscience for antibodies that will be incorporated into Kriya’s AAV platform for treating cancer. The latest move with Redpin is intended to be Kriya’s informal arrival to the neurology scene. Kriya’s pipeline-building strategy has been paired with an even more deliberate focus on manufacturing. Kriya invested early in establishing its own facility, which is now operational, thanks in part to $370 million in financing that’s been raised over the last year and a half.  “Our goal at the company is to put together the right pieces—both technical and operational—to actually elevate gene therapy to address a much broader universe of diseases,” Kriya CEO Shankar Ramaswamy, M.D., said at Fierce Biotech’s Cell & Gene Therapy Forum earlier this month. “And if you operate through that lens, manufacturing is really fundamental to doing anything in gene therapy.”  Still, Ramaswamy was clear the company’s overarching goal is not to be a contract manufacturing organization but to actually produce meaningful medicines. Kriya has yet to unveil its full pipeline, but Ramaswamy’s hope is that by next year, Kriya is either in the clinic with some of its first programs or quickly approaching it.

Courtesy of Getty Images When Kriya Therapeutics emerged from stealth mode in 2020 with $80.5 million in Series A funds, the company’s pipeline featured AAV-based gene therapies for diabetes and severe obesity. Now, Kriya, a BioSpace NextGen 2021 winner, is building its neurology pipeline with the acquisition of Redpin Therapeutics. Redpin’s chemogenetics platform, focused on targeted cell and gene therapies for intractable diseases of the nervous system, is a potentially lucrative pick-up for Kriya. The CNS and gene therapy spaces have been among the hottest in 2022, receiving substantial investment. In the acquisition, announced Wednesday, Kriya picks up Redpin’s neurology pipeline, which includes two gene therapy programs focused on epilepsy and trigeminal neuralgia (TN). Redpin’s technology selectively activates or silences disease-causing neurons while leaving normal functioning cells unaffected, according to a press statement issued by Kriya. The company’s proprietary platform leverages controllable gene therapy to express engineered ion channels that are responsive to modulation by the anti-smoking drug varenicline. This enables the inhibition of specific overactive neurons or the stimulation of underactive ones. In September 2021, Redpin announced the grant of four new patents by the U.S. Patent and Trademark Office for a class of modified ligand-gated ion channels based on the ligand binding domain of the α nicotinic acetylcholine receptor and their use. The coverage, which includes varenicline, extends until 2038. The hope is that chemogenetics can help overcome the limited efficacy and off-target side effects seen with systemically administered drugs or surgical interventions for local neuron dysfunction, Kriya noted. In a statement, Dr. Elma Hawkins, president, CEO and co-founder of Redpin, said Kriya is the “perfect company to take this leading ion channel-based platform forward and deliver an effective treatment option for patients.” Shankar Ramaswamy, M.D., co-founder and CEO of Kriya, said the company looks forward to integrating Redpin’s platform and pipeline into its gene therapy engine. “Redpin’s innovative chemogenetics platform has the potential to transform the lives of patients suffering from intractable neurological conditions,” he said in a statement. Kriya currently states four focus areas: ophthalmology, oncology, rare disease and chronic disease. Kriya has been busy acquiring assets and leadership as it builds out these divisions. In January, it acquired Warden Bio and its five investigational gene therapy programs for glycogen storage disorders that have no available treatments. Then, in August, Kriya tapped Genzyme and Inozyme veteren Pedro Huertas as chief medical officer of the rare disease division. Terms and financials of the Redpin deal were not announced. BioSpace has reached out to both Kriya and Redpin and will update this story accordingly.